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CSA C22.2 NO 60601-2-50

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

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Organization: CSA
Publication Date: 1 January 2010
Status: active
Page Count: 88
ICS Code (Therapy equipment): 11.040.60
scope:

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information see IEC 80601-2-35;

- INFANT INCUBATORS; for information see IEC 60601-2-19;

- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;

- INFANT RADIANT WARMERS; for information see IEC 60601-2-21.

Document History

CSA C22.2 NO 60601-2-50
January 1, 2010
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME...
Amendment 1 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
FOREWORD This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice. Full information on the voting for...
Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME...
Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME...
Medical electrical equipment – Part 2-50: Particular requirements for the safety of infant phototherapy equipment
A description is not available for this item.
Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
A description is not available for this item.
Medical electrical equipment – Part 2-50: Particular requirements for the safety of infant phototherapy equipment
A description is not available for this item.

References

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